Pfizer’s Oral JAK Trial Meets RA Endpoint

Pfizer achieved positive results from the ORAL Scan Phase III study of tofacitinib, an investigational oral JAK inhibitor, in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). Patients were randomized to receive tofacitinib 5 or 10 mg BID or placebo added to background MTX.

The study met all primary endpoints at the 10 mg BID dose, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, reducing the progression of structural damage at six months, improving physical function at three months, and in reaching DAS28-4 (ESR) <2.6 at six months.

For the 5 mg BID dose, the study demonstrated statistically significant improvements versus placebo in at six months, but the difference from placebo in mTSS did not reach statistical significance at six months.